Augmented Whole-body Scanning Via Magnifying PET/CT (AWSM-PET/CT) Techniques Abilities to Improve Upon the Diagnostic Accuracy of the Standard-of-care (SOC) FDG PET/CT for Malignant Lesion Detection

Cancer Clinical Trial

Official title:

A Prospective Study of the Augmented Whole-body Scanning Via Magnifying PET/CT (AWSM-PET/CT) Techniques Abilities to Improve Upon the Diagnostic Accuracy of the Standard-of-care (SOC) FDG PET/CT for Malignant Lesion Detection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05513027
• Other study ID #: 202207154
• Secondary ID: 1R01CA233912
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2024
• Est. completion date: May 31, 2027

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: Yuan-Chuan Tai, Ph.D.
• Phone: 314-362-8429
• Email: taiy[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) has been demonstrated to outperform other imaging modalities such as CT and magnetic resonance imaging (MRI) for the detection of metastatic cancers. Therefore, it is currently used for cancer staging, re-staging, and for monitoring response to therapy for many types of cancers. Despite its wide use and success, the diagnostic accuracy of FDG-PET/CT is suboptimal for lesions that are significantly smaller than 1 cm due primarily to limitations on image resolution and system sensitivity. The investigators have developed an Augmented Whole-body Scanning via Magnifying PET (AWSM-PET) technology that can improve the image resolution and system sensitivity of current and future PET/CT scanners. This study will evaluate preliminarily whether the AWSM-PET/CT technology can provide additional high-resolution PET/CT images displayed concurrently with the standard of care FDG-PET/CT images to improve overall accuracy in depicting malignant lesions in cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patient 18 years of age or older
• Patient with suspected or pathologically confirmed diagnosis of carcinoma scheduled to undergo standard of care (SOC) FDG-PET/CT for initial diagnosis, initial staging, or suspected recurrence. Preference is to enroll those subjects who will undergo biopsy or surgical resection prior to other cancer treatment.
• Willing to undergo FDG-PET/CT imaging with AWSM-PET.
• Patients of child-bearing potential must have a negative urine pregnancy test on the day of the PET/CT scan. Postmenopausal women who self-report as amenorrheic for at least 12 consecutive months are to be considered not of child-bearing potential.
• Patients must be able to understand and sign an IRB-approved informed consent form that allows access to prior medical records, participation in the study and chart review follow up.
• Patients are able to tolerate up to approximately 30 min of PET imaging.

Exclusion Criteria:

• Patients who have poorly controlled diabetes (fasting blood glucose > 200 mg/dL obtained directly prior to FDG administration for PET/CT scan)
• Patients whose weight is over 250 lbs or whose body habitus prohibits the AWSM-PET insert device from being placed at the end of the imaging field of view

Related Conditions & MeSH terms

• Cancer

Intervention

Device:
• Augmented Whole-body Scanning via Magnifying PET
-Added at the end of the SOC FDG-PET/CT scan. Will take approximately 3-5 minutes longer.
• FDG-PET/CT
-Standard of care

Drug:
• 18F- fluorodeoxyglucose
-Standard of care given with FDG-PET/CT

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	True presence and absence of malignancy in each lesion	The true presence and absence of malignancy in each lesion (binary reference standard), will be obtained through multiple sources including pathology report of surgically removed or biopsied tissues, imaging follow-up and clinical follow-up. The separately reconstructed SOC FDG-PET/CT and the AWSM PET/CT imaging reading of each lesion will be graded by two raters, separately, via a five-point scale: 1 = definitely benign; 2 = probably benign; 3 = equivocal; 4 = probably malignant; and 5 = definitely malignant. For patients who proceed to surgery or biopsy and histopathologic results are available, the two sets of images with be compared and correlated with the histopathologic results. Each scan will be graded in concordance with the reference standard as true positive, true negative, false positive or false negative. If there is a question about lesion location corresponding to the same area on imaging and pathology additional resources such as the operative report will be utilized.	Through 9 months after completion of scan
Primary	Image reading of each lesion on SOC FDG-PET/CT	SOC FDG-PET/CT image reading of each lesion, will be graded by two raters, separately, via a five-point scale: 1 = definitely benign; 2 = probably benign; 3 = equivocal; 4 = probably malignant; and 5 = definitely malignant.	Through 45 days after completion of scan
Primary	Image reading of each lesion on AWSM-PET/CT	AWSM PET/CT image reading of each lesion, will be graded by two raters, separately, via a five-point scale: 1 = definitely benign; 2 = probably benign; 3 = equivocal; 4 = probably malignant; and 5 = definitely malignant.	Through 45 days after completion of scan
Secondary	To assess whether a nuclear medicine physician's confidence is altered by the AWSM-PET/CT technology	Evaluate whether the indefinite ratings (score of 2-4) for SOC FDG PET/CT is changed to a definitive category (categories 1 and 5) by the AWSM-PET/CT. A study specific review outside of the SOC FDG-PET/CT report will be conducted by 2 certified nuclear medicine physicians in batch analyses. The batch analyeses will occur in groups of 3 participants and will be completed within 21 days after the 3rd partcipant's AWSM-PET/CT has been reconstructed. Both physicians will review the SOC PET/CT followed by review of the SOC PET/CT with the AWSM-PET/CT as supplemental imaging. Up to 4 lesions will be recorded and graded according to a five-point scale: 1 = definitely benign; 2 = probably benign; 3 = equivocal; 4 = probably malignant; and 5 = definitely malignant	Through 45 days after completion of scan
Secondary	Image quality score	Image quality score of the SOC FDG PET/CT and the AWSM-PET/CT images will be compared to confirm that the simultaneously acquired scans are both of diagnostic quality. A study specific review outside of the SOC FDG-PET/CT report will be conducted by 2 certified nuclear medicine physicians in batch analyses. The batch analyeses will occur in groups of 3 participants and will be completed within 21 days after the 3rd partcipant's AWSM-PET/CT has been reconstructed. Both physicians will review the SOC PET/CT followed by review of the SOC PET/CT with the AWSM-PET/CT as supplemental imaging.; Overall quality of the assigned scan will be evaluated and graded on a 4 point scale: 1= Poor uninterpretable; 2= Poor acceptable for review; 3= Fair; 4= Good/Diagnostic.	Through 45 days after completion of scan
Secondary	Tolerability as measured by number of patients who find the scan intolerable and have to terminate the study		Through completion of study (estimated to be 30 months)
Secondary	Tolerability as measured by overall comfort of the scan	The overall comfort during the last 3-5 minutes of the scan (added due to the AWSM-PET/CT technology) as compared to the first 15-20 minutes of the scan (for a typical SOC FDG-PET/CT). This will be reported via a five-point scale: 1 = extremely uncomfortable, unbearable; 2 = somewhat uncomfortable but bearable; 3 = neutral, neither comfortable nor uncomfortable; 4 = somewhat comfortable; 5 = very comfortable and relaxing.	Through completion of scan (Day 1)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine